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PROGRAF is a brand name for Tacrolimus, supplied as a capsule. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Transplantation Prograf® (tacrolimus) is indicated for: • prophylaxis of organ rejection in patients receiving allogeneic liver, kidney or heart transplants. • treatment of refractory rejection in patients receiving allogeneic liver or kidney transplants. Prograf is to be used concomitantly with adrenal…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations Due to intersubject variability following dosing with tacrolimus, individualization of the dosing regimen is necessary for optimal therapy. Additional factors that may impact dosing include pre-existing conditions, such as renal or hepatic impairment, race, pediatric use and the concomitant use of other medications.
Prograf has been used in combination with azathioprine. Prograf has been used in combination with mycophenolate mofetil (MMF) in patients receiving deceased donor kidney transplants and heart Prograf® (tacrolimus) Page 7 of 87 Protected B / Protégé B transplants.
Because of the risk of anaphylaxis, intravenous Prograf should be reserved for patients unable to take Prograf capsules orally. Medication errors, including inadvertent, unintentional or unsupervised substitution of Prograf (immediate-release) or Advagraf (extended-release) tacrolimus formulations, have been observed.
This has led to serious adverse events, including graft rejection, or other side effects which could be a consequence of either under- or over-exposure to tacrolimus. Patients should be maintained on a single formulation of tacrolimus with the corresponding daily dosing regimen; alterations in formulation or regimen should only take place under the close supervision of a transplant specialist.
Following conversion to any alternative formulation, therapeutic drug monitoring must be performed and dose adjustments made to ensure that systemic exposure to tacrolimus is maintained. 2 Recommended Dose and Dosage Adjustment Prograf (tacrolimus for injection) is for intravenous (IV) use in transplant patients only.
Anaphylactic reactions have occurred with injectables containing castor oil derivatives (see 7 WARNINGS AND PRECAUTIONS). In patients unable to take oral Prograf (tacrolimus immediate-release capsules, USP), therapy may be initiated with IV Prograf (tacrolimus for injection).
The initial dose of Prograf should be administered no sooner than 6 hours after transplantation. 05 mg/kg/day (liver, kidney) as a continuous intravenous infusion (see Table 1). Adult patients should receive doses at the lower end of the dosing range.
Concomitant adrenal corticosteroid therapy is recommended early post-transplantation. Continuous intravenous infusion of Prograf (tacrolimus for injection) should be continued until the patient can tolerate oral administration of Prograf (tacrolimus immediate-release capsules, USP).
1 Adverse Reaction Overview Kidney Transplantation The most common adverse reactions reported were infection, tremor, hypertension, decreased renal function, constipation, diarrhea, headache, abdominal pain and insomnia. Many of these adverse reactions were mild and responded to a reduction in dosage.
Insulin-dependent post-transplant diabetes mellitus (PTDM) was related to increased whole blood trough concentrations of tacrolimus and higher doses of corticosteroids. The median time to onset of PTDM was 68 days. Liver Transplantation The principal adverse reactions of Prograf (tacrolimus) are tremor, headache, diarrhea, hypertension, nausea, and renal dysfunction.
These occur with oral and intravenous administration of Prograf and may respond to a reduction in dosing. Diarrhea was sometimes associated with other gastrointestinal complaints such as nausea and vomiting. Hyperkalemia and hypomagnesemia have occurred in patients receiving Prograf therapy.
Hyperglycemia has been noted in many patients; some may require insulin therapy. Heart Transplantation The more common adverse reactions in Prograf-treated heart transplant recipients were kidney function abnormal, hypertension, diabetes mellitus, CMV infection, tremor, hyperglycemia, leukopenia, infection, and hyperlipemia.
Rheumatoid Arthritis The adverse events associated with Prograf treatment in rheumatoid arthritis patients occurred at a lower rate of incidence than seen in transplant patients receiving Prograf. The majority of adverse events were mild or moderate in intensity, of limited duration and did not result in discontinuation of the study drug.
2 Clinical Trial Adverse Reactions Because clinical trials are conducted under very specific conditions, the adverse reaction rates observed in the clinical trials may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug.
1 Pregnancy 2025/12 TABLE OF CONTENTS RECENT MAJOR LABEL CHANGES ............................................................................................. 2 TABLE OF CONTENTS ...............................................................................................................
2 PART 1: HEALTHCARE PROFESSIONAL INFORMATION ............................................................. 5 1 INDICATIONS ....................................................................................................................
1 Pediatrics ................................................................................................................... 2 Geriatrics ...................................................................................................................
6 2 CONTRAINDICATIONS ....................................................................................................... 6 3 SERIOUS WARNINGS AND PRECAUTIONS BOX..................................................................
6 4 DOSAGE AND ADMINISTRATION ...................................................................................... 1 Dosing Considerations ...............................................................................................
2 Recommended Dose and Dosage Adjustment .......................................................... 3 Reconstitution ........................................................................................................... 4 Administration ...........................................................................................................
5 Missed Dose ............................................................................................................ 10 5 OVERDOSE......................................................................................................................
• Prograf (tacrolimus) is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container. For a complete listing, see the 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING sections.
• Prograf (tacrolimus for injection) is contraindicated in patients with a hypersensitivity to HCO-60 (polyoxyl 60 hydrogenated castor oil).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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3 mg/kg/day administered every 12 hours in two divided doses. The initial dose of Prograf may be administered within 24 hours of transplantation but should be delayed until renal function has recovered (as indicated, for example, by a serum creatinine < 4 mg/dL).
Black patients may require higher doses to achieve comparable blood levels. Dosage and typical tacrolimus whole blood trough concentrations are shown in the table below; blood concentration details are described under 7 Warnings and Precautions– Monitoring and Laboratory Tests - Blood Concentration Monitoring.
3 mg/kg/day Dosing Regimen two divided doses, q12h Typical tacrolimus whole blood trough concentrations Month 1-3 Month 4-12 7 - 20 ng/mL 5 - 15 ng/mL Prograf® (tacrolimus) Page 8 of 87 Protected B / Protégé B Liver Transplantation It is recommended that patients be converted from IV to oral Prograf as soon as oral therapy can be tolerated.
This usually occurs within 2-3 days. The first dose of oral therapy should be given 8-12 hours after discontinuing the IV infusion. 15 mg/kg/day administered in two divided daily doses every 12 hours. The initial dose of Prograf should be administered no sooner than 6 hours after transplantation.
Adult patients should receive doses at the lower end of the dosing range. Some centres use lower Prograf doses during maintenance therapy post-transplantation. Dosing should be titrated based on clinical assessment of rejection and tolerability.
Adjunct therapy with adrenal corticosteroids is recommended early post-transplant. 075 mg/kg/day administered every 12 hours in two divided doses. It is recommended that patients initiate oral therapy with Prograf capsules if possible.
If IV therapy is necessary, conversion from IV to oral Prograf is recommended as soon as oral therapy can be tolerated. This usually occurs within 2-3 days. The initial dose of Prograf should be administered no sooner than 6 hours after transplantation.
In a patient receiving an IV infusion, the first dose of oral therapy should be given 8-12 hours after discontinuing the IV infusion. Dosing should be titrated based on clinical assessments of rejection and tolerability. Lower Prograf dosages may be sufficient as maintenance therapy.
Adjunct therapy with adrenal corticosteroids is recommended early post-transplant. Rheumatoid Arthritis The recommended adult oral dose of Prograf is 3 mg, administered once a day. Regular monitoring of Prograf-treated patients for occurrence of adverse events is mandatory.
Patients with Hepatic or Renal Dysfunction Due to the potential for nephrotoxicity, patients with renal or hepatic impairment should receive doses at the lowest value of the recommended intravenous and oral dosing ranges. Further reductions in dose below these ranges may be required.
Conversion from Cyclosporine to Prograf Tacrolimus should not be used simultaneously with cyclosporine. Patients converted from cyclosporine to Prograf should receive the first Prograf dose no sooner than 24 hours after the last cyclosporine dose.
Dosing may be further delayed in the presence of elevated […]
Adverse reaction information from clinical trials is useful for identifying drug-related adverse events and for approximating rates. Kidney Transplantation The incidence of adverse events was determined in two randomized Phase III comparative kidney transplant studies involving 508 patients receiving Prograf and 352 patients receiving cyclosporine.
S. STUDY EUROPEAN STUDY Prograf N=205 % CBIR** N=207 % Prograf N=303 % CBIR** N=145 % Nervous System Tremor* Headache* Insomnia 54 44 32 34 38 30 35 21 24 12 14 26 Gastrointestinal Diarrhea Nausea Constipation Vomiting Dyspepsia 44 38 35 29 28 41 36 43 23 20 22 17 31 13 16 10 16 35 8 13 Cardiovascular Hypertension* 50 52 37 39 Urogenital Creatinine increased* 45 42 35 21 Metabolic and Nutritional Hypophosphatemia Hypomagnesemia Hyperkalemia* Diabetes mellitus* Hyperglycemia* 49 34 31 24 22 53 17 32 9 16 3 4 21 12 16 5 1 16 2 7 Hemic and Lymphatic Anemia Leukopenia 30 15 24 17 18 17 17 15 Body as a Whole Infection Peripheral edema Asthenia Abdominal pain Pain Fever 45 36 34 33 32 29 49 48 30 31 30 29 76 16 7 27 21 8 75 16 4 23 23 9 Respiratory System Dyspnea 22 18 12 11 Musculoskeletal Arthralgia 25 24 9 10 * See Warnings and Precautions Prograf® (tacrolimus) Page 22 of 87 Protected B / Protégé B ** Cyclosporine-based immunosuppressive regimen.
Tacrolimus has been studied in combination with azathioprine and steroids (triple therapy) in recipients of kidney transplants. In a Phase II European trial, tacrolimus triple therapy was administered to 31 adults receiving deceased donor kidney transplants.
Within six weeks post-transplant, there were no deaths or graft losses. 4%) experienced acute rejection, with one patient experiencing corticosteroid-resistant rejection. 7%) developed transient hyperglycemia, but no patient required long-term therapy for diabetes.
8%) (Transpl Int 1995; 8:86-90). The University of Pittsburgh has studied double therapy (tacrolimus and steroids) compared to triple therapy in 204 adult recipients of kidney transplants between August 1991 and October 1992. (Clin Transplantation 1994; 8:508-515).
The one year actuarial patient and graft survival of double therapy were 95 and 90% versus 91 and 82% for triple therapy (p=NS). The incidence of rejection was significantly lower with triple therapy in deceased donor recipients (39% versus 58%) but not significantly different in recipients from living related donors.
7% of triple therapy patients. S. Phase II trial studied 92 adult recipients of deceased donor kidney transplants randomized to three target whole blood concentration ranges of tacrolimus. All patients received antilymphoblast globulin induction with azathioprine and steroids followed by tacrolimus triple therapy initiated within 2 weeks post-transplant.
With follow-up to six weeks post-transplant, there were no patient deaths, and one graft loss. The incidence of rejection was 14% combining all tacrolimus treatment groups. Adverse events requiring dose reduction were significantly associated with target tacrolimus blood concentrations (36%-62%).
Data on the safety and efficacy of tacrolimus in combination with immunosuppressants other than steroids in liver transplant patients is more limited. In the European multicentre liver transplant study, many patients received azathioprine or ATG/ALG when tacrolimus therapy was withheld.
Seven patients received azathioprine in combination with tacrolimus and steroids. Of these 7 patients, one […]
10 6 DOSAGE FORMS, STRENGTHS, COMPOSITION, AND PACKAGING ................................... 10 7 WARNINGS AND PRECAUTIONS...................................................................................... 11 General ................................................................................................................................
11 Carcinogenesis and Genotoxicity ......................................................................................... 12 Cardiovascular .....................................................................................................................
12 Driving and Operating Machinery ........................................................................................ 13 Gastrointestinal ...................................................................................................................
13 Hematologic......................................................................................................................... 13 Hepatic/Biliary/Pancreatic ...................................................................................................
13 Immune ............................................................................................................................... 14 Prograf® (tacrolimus) Page 3 of 87 Protected B / Protégé B Monitoring and Laboratory Tests ........................................................................................
14 Neurologic ........................................................................................................................... 16 Renal ....................................................................................................................................
17 Reproductive Health ............................................................................................................ 1 Special Populations..................................................................................................
1 Pregnancy ........................................................................................................ 2 Breastfeeding .................................................................................................. 3 Pediatrics .........................................................................................................
4 Geriatrics ......................................................................................................... 20 8 ADVERSE REACTIONS......................................................................................................
1 Adverse Reaction Overview ..................................................................................... 2 Clinical Trial Adverse Reactions ............................................................................... 3 Less Common Clinical Trial Adverse Reactions ........................................................
4 Abnormal Laboratory Findings: Hematologic, Clinical Chemistry, and Other Quantitative Data ................................................................................................................ 5 Post-Market Adverse Reactions ..............................................................................
33 9 DRUG INTERACTIONS ..................................................................................................... 2 Drug Interactions Overview .....................................................................................
3 Drug-Behaviour Interactions ................................................................................... 4 Drug-Drug Interactions ............................................................................................ 5 Drug-Food Interactions............................................................................................
6 Drug-Herb Interactions ............................................................................................ 7 […]